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Hydrogen Peroxide Sterilization

It was recently announced that Martell Winters, B.S., RM/SM(NRCM) was appointed and approved as convenor for a three-year term of a new ISO working group, WG16, on vaporized hydrogen peroxide sterilization. The new working group is tasked with developing a new standard to provide requirements and guidance for developing sterilization processes for vaporized hydrogen peroxide. The ISO document has been named ISO 22441, Sterilization of healthcare products – Low temperature vaporized hydrogen peroxide – Requirements for the development, validation and routine control of a sterilization process for medical devices.

“I’m honored to be considered and appointed as convenor of WG16,” Martell said about the appointment. “I look forward to working with the members of the group as we develop this new standard. There are a good number of experts in vaporized hydrogen peroxide involved, so I am confident that our efforts will result in a technically correct and useful standard.”

Previously, vaporized hydrogen peroxide sterilization was addressed under the general sterilization criterial standard, ISO 14937, which provides general requirements for any sterilizing agent which does not already have a specific standard. It was felt by the international community that vaporized hydrogen peroxide had gained enough acceptance and use in the industry that it merited having its own standard.

The US body which will be participating in this ISO working group will be AAMI WG16, which is also a new working group and is currently being established. Anyone who has interest in being involved with this new AAMI working group should contact AAMI.